FDA product code LDX: Fixative, Metallic Containing
LDX is the FDA product code for fixative, metallic containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under LDX. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Fixative, Metallic Containing |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LDX clearance
Top LDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anatech, Ltd. | 1 | 1988-07-28 |
Most recent LDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882874 | Anatech, Ltd. | ZINC FORMALIN | 1988-07-28 | 17 |
Recalls for LDX devices
openFDA lists no recalls for product code LDX.
Frequently asked questions
What is FDA product code LDX?
LDX is the FDA product code for fixative, metallic containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is LDX?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDX?
Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most LDX clearances?
Anatech, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDX
- Run a recall and safety report across every LDX manufacturer
- Watch product code LDX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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